Compare efficacy of Quetiapine with placebo in the treatment of bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21

Secondary Outcome Measures:

Compare the effect of Quetiapine with placebo in change from baseline to Day 21 percentage of patients with response, defined as a ≤ 12, evaluate safety and tolerability

Enrollment:

220

Study Start Date:

July 2004

Study Completion Date:

July 2006

Eligibility

Ages Eligible for Study:

10 Years to 17 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures

Patient has a documented clinical diagnosis of Bipolar I mania

Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit

Exclusion Criteria:

Patients (female) must not be pregnant or lactating

Patients with a known intolerance or lack of response to previous treatment with quetiapine

Patients who have previously participated in this study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090311